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# Cogentin Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/cogentin-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-11-09T12:00:00.000Z
- Updated: 2026-09-14T14:15:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155760

*Federal Register* notice: FDA has determined that Akorn’s Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Cogentin is indicated for use as an add-on therapy for Parkinson’s, and for the control of extrapyramidal disorders (except tardive dyskinesia) due to neuroleptic drugs (e.g., phenothiazines). To view the notice, click [here](https://public-inspection.federalregister.gov/2023-24882.pdf?ref=fdaweb.com).